TY - JOUR
T1 - Commitments by the biopharmaceutical industry to clinical trials transparency: the evolving environment
JF - bioRxiv
DO - 10.1101/349902
SP - 349902
AU - Baronikova, Slavka
AU - Purvis, Jim
AU - Southam, Eric
AU - Beeso, Julie
AU - Winchester, Christopher
AU - Panayi, Antonia
Y1 - 2018/01/01
UR - http://biorxiv.org/content/early/2018/11/12/349902.abstract
N2 - Background: Sponsors of clinical trials have ethical obligations to register protocols, to report study results and to comply with applicable legal requirements. Objective: To evaluate public commitments to trial disclosure and rates of disclosure by members and nonminusmembers of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and/or the Pharmaceutical Research and Manufacturers of America (PhRMA). Study selection: Websites of the top 50 biopharmaceutical companies by 2015 sales were searched for statements relating to trial data disclosure. Disclosure of trial results completed by biopharmaceutical industry and non-industry sponsors of at least 30 trials (2006minus2015) was assessed using TrialsTracker. Findings: Among the top 50 companies, 30 were EFPIA/PhRMA members and 20 were non-members, of which 26 and none, respectively, had a statement on their website committing to the disclosure of trials data. Of 29 377 trials in TrialsTracker, 9511 were industry-sponsored (69 companies) and 19 866 were non-industry-sponsored (254 institutions). The overall mean disclosure rate was 55%, with higher rates for industry (74%) than for non-industry sponsors (46%). Of the 30 companies within the top 50 with data in TrialsTracker, the mean disclosure rate was 76% (77% for EFPIA/PhRMA members [n = 25] versus 67% for non-members [n = 5]). Conclusions: Most of the top 50 biopharmaceutical companies have publicly committed to the disclosure of trial data. Industry sponsors have responded to the ethical and legal demands of trial disclosure to a greater extent than non-industry sponsors, and now disclose three quarters of their trials.
ER -